Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Page 7 of 13)
14.2 Efficacy of 2-Dose Primary Series of Pfizer-BioNTech COVID-19 Vaccine (Original Monovalent) in Participants 12 Through 15 Years of Age
A descriptive efficacy analysis of Study 2 has been performed in approximately 2,200 participants 12 through 15 years of age evaluating confirmed COVID-19 cases accrued up to a data cutoff date of March 13, 2021.
The efficacy information in participants 12 through 15 years of age is presented in Table 16.
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting). | |||
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First COVID-19 occurrence from 7 days after Dose 2 in participants 12 through 15 years of age without evidence of prior SARS-CoV-2 infection * | |||
Pfizer-BioNTech COVID-19 Vaccine † N ‡ =1005 Cases n1 § Surveillance Time ¶ (n2 # ) | Vaccine Efficacy % (95% CI Þ ) | ||
Participants 12 through 15 years of age | 00.154 (1001) | 160.147 (972) | 100.0(75.3, 100.0) |
First COVID-19 occurrence from 7 days after Dose 2 in participants 12 through 15 years of age with or without evidence of prior SARS-CoV-2 infection | |||
Pfizer-BioNTech COVID-19 Vaccine † N ‡ =1119 Cases n1 § Surveillance Time ¶ (n2 # ) | Vaccine Efficacy % (95% CI Þ ) | ||
Participants 12 through 15 years of age | 00.170 (1109) | 180.163 (1094) | 100.0(78.1, 100.0) |
14.3 Efficacy of 2-Dose Primary Series of Pfizer-BioNTech COVID-19 Vaccine (Original Monovalent) in Participants 5 Through 11 Years of Age
A descriptive efficacy analysis of Study 3 has been performed in 1,968 participants 5 through 11 years of age without evidence of infection prior to 7 days after Dose 2. This analysis evaluated confirmed symptomatic COVID-19 cases accrued up to a data cutoff date of October 8, 2021.
Table 17 presents the specific demographic characteristics in participants who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose.
Pfizer-BioNTech COVID-19 Vaccine * 10 mcg/Dose (N † =1305) n ‡ (%) | Placebo (N † =663) n ‡ (%) | |
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Sex | ||
Male | 679 (52.0) | 343 (51.7) |
Female | 626 (48.0) | 320 (48.3) |
Age at Vaccination | ||
Mean (SD) | 8.2 (1.93) | 8.1 (1.98) |
Median | 8.0 | 8.0 |
Min, max | (5, 11) | (5, 11) |
Race | ||
White | 1018 (78.0) | 514 (77.5) |
Black or African American | 76 (5.8) | 48 (7.2) |
American Indian or Alaska Native | <1.0% | <1.0% |
Asian | 86 (6.6) | 46 (6.9) |
Native Hawaiian or other Pacific Islander | <1.0% | <1.0% |
Other § | 110 (8.4) | 52 (7.8) |
Ethnicity | ||
Hispanic or Latino | 243 (18.6) | 130 (19.6) |
Not Hispanic or Latino | 1059 (81.1) | 533 (80.4) |
Not reported | <1.0% | <1.0% |
Comorbidities ¶ | ||
Yes | 262 (20.1) | 133 (20.1) |
No | 1043 (79.9) | 530 (79.9) |
The descriptive vaccine efficacy results in participants 5 through 11 years of age without evidence of prior SARS-CoV-2 infection are presented in Table 18. None of the cases accrued met criteria for severe COVID-19 or multisystem inflammatory syndrome in children (MIS-C). No cases of COVID-19 were observed in either the vaccine group or the placebo group in participants with evidence of prior SARS-CoV-2 infection.
First COVID-19 occurrence from 7 days after Dose 2 in participants 5 through 11 years of age without evidence of prior SARS-CoV-2 infection * | |||
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Pfizer-BioNTech COVID-19 Vaccine † 10 mcg/dose N ‡ =1305 Cases n1 § Surveillance Time ¶ (n2 # ) | Placebo N ‡ =663 Cases n1 § Surveillance Time ¶ (n2 # ) | Vaccine Efficacy % (95% CI) | |
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting). | |||
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Participants 5 through 11 years of age | 30.322 (1273) | 160.159 (637) | 90.7(67.7, 98.3) |
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